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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Children's Hospital Medical Center, Cincinnati |
|---|---|
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00005890 |
Purpose
OBJECTIVES:
I. Examine adrenal cortical function and the incidence of adrenal dysfunction in children with septic shock.
II. Examine the mortality, length of stay in the PICU, and incidence of multiorgan failure in children with adrenal dysfunction and septic shock.
| Condition | Intervention |
|---|---|
|
Septic Shock |
Drug: corticotropin |
| Study Type: | Interventional |
| Study Design: | Diagnostic |
| Estimated Enrollment: | 56 |
| Study Start Date: | March 1996 |
PROTOCOL OUTLINE:
Patients undergo a corticotropin stimulation test within 8 hours of admission to the PICU. Blood samples for plasma cortisol and corticotropin levels are drawn at time 0 followed by corticotropin 1-24 IV. Additional cortisol levels are drawn at 30 and 60 minutes. Corticotropin is measured by immunoradiometric assay and cortisol is measured by radioimmunoassay. Mean arterial blood pressure, heart rate, and respiratory rate are recorded at baseline and at 60 minutes.
Patients receive routine management for septic shock and multiple organ system failure.
Eligibility| Ages Eligible for Study: | 1 Month to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Patients admitted to the PICU with septic shock; Hypotension (systolic blood pressure less than 2 standard deviations below age normal) plus 3 or more of the following: temperature greater than 38 or less than 36 degrees Celsius; heart rate greater than 90th percentile for age; respiratory rate greater than 90th percentile for age; WBC greater than 12,000/mm3 or less than 4,000/mm3 or greater than 10% band forms; perfusion abnormalities including lactic acidosis, oliguria, or an acute alteration in mental status
Arterial or central venous catheter in place
--Prior/Concurrent Therapy--
At least one month since prior corticosteroids
--Patient Characteristics--
Renal: No nephrotic syndrome requiring glucocorticoids
Pulmonary: No asthma requiring glucocorticoids
Other: No condition requiring glucocorticoids (e.g., adrenal insufficiency); No uncontrolled diabetes mellitus; No prior adrenal dysfunction (plasma cortisol concentration less than 19 mcg/dL 30 and 60 minutes post corticotropin stimulation); No hypersensitivity to corticotropin
Contacts and Locations| United States, Ohio | |
| Children's Hospital Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Study Chair: | Richard J. Brilli | Children's Hospital Medical Center, Cincinnati |
More Information
| Study ID Numbers: | NCRR-M01RR08084-0043, CHMC-C-96-3-5 |
| Study First Received: | June 2, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00005890 History of Changes |
| Health Authority: | United States: Federal Government |
|
immunologic disorders and infectious disorders rare disease sepsis septic shock |
|
Systemic Inflammatory Response Syndrome Sepsis Shock Hormone Antagonists Shock, Septic Hormones, Hormone Substitutes, and Hormone Antagonists |
Rare Diseases Epinephrine Hormones Adrenocorticotropic Hormone Inflammation |
|
Systemic Inflammatory Response Syndrome Sepsis Pathologic Processes Shock Physiological Effects of Drugs Shock, Septic |
Hormones, Hormone Substitutes, and Hormone Antagonists Infection Hormones Pharmacologic Actions Adrenocorticotropic Hormone Inflammation |
